About
SMAC is the trusted, data-focused consulting firm chosen by biopharmaceutical companies for our dedication to providing comprehensive, integrated solutions in all aspects of drug development and lifecycle management. Since 2019, we have supported 100+ biotechnology, diagnostic, and biopharmaceutical companies from preclinical through commercialization, with expertise across many therapeutic areas.
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Our expertise spans preclinical to launch: clinical development, regulatory strategy, medical affairs, biometrics, statistical science, microbiology, medical and scientific communication, team education and training, and non-dilutive funding identification and application. Each engagement is grounded in the scientific and regulatory specifics of the asset, and our deliverables are built to withstand agency, payer, and peer scientific review.
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We deliver strategic, in-depth insight focused on the long-term success of our clients and their assets. This approach means every stage of development is managed with intent, from initial IND submissions through marketing authorization approvals and post-approval activities. What sets SMAC apart is a disciplined, data-driven methodology and a commitment to tailored solutions that move programs and projects to success.
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SMAC is a women-owned business, certified through WBENC, with experience supporting federally funded programs and the requirements of government contracting.
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Explore our solutions to see how SMAC helps sponsors advance their programs with scientific rigor, precision, and confidence.
Meet the Team
Our team combines clinical development, regulatory, biometrics, medical affairs, and commercial leadership. We have direct, hands-on experience advancing FDA-approved infectious disease, immunology, rare disease, and critical care therapies and diagnostics.
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Judith Steenbergen, PhD
CEO and Founder
20+ years of senior Medical Affairs and Clinical Development leadership. She has a demonstrated record of success, resulting in regulatory approval and launch of multiple therapeutic agents (daptomycin, ceftolozane/tazobactam, omadacycline). She has experience with a range of IND/NDA/MAA filings, FDA advisory boards, and CLSI/EUCAST breakpoint negotiations. She has built medical affairs organizations from the ground up and brings deep expertise in medical affairs strategy and execution.
Hina Patel, PharmD, BCPS
Founding Member and Medical Affairs Lead
15+ years in pharmaceutical MA, including field-based MSL and leadership roles, MA buildout, product strategy, business development, government affairs, and global expansion.
Amira Bhalodi, PharmD
Pharmacokinetics and Pharmacodynamics Lead
Clinical pharmacist with expertise in infectious diseases scientific strategy, dose justification, PK/PD, publication planning, and healthcare stakeholder engagement.
Rolf Wagenaar
Education and Training Lead
30 years in commercial leadership. Successfully led launch and commercial efforts for 8 infectious disease products. Moderated 75+ advisory boards. He began his career as an educator, and training teams on the scientific and commercial nuances behind a successful specialty launch remains the work he enjoys most.
Shelley Campeau, PhD, D(ABMM)
Clinical Microbiology and Diagnostic Lead
Board-certified clinical microbiologist with expertise in AST development, in vitro diagnostic FDA-regulated studies, and breakpoint submissions.
Elizabeth L. Alexander, MD, MSc, FIDSA
Clinical Development Lead
Board-certified infectious disease physician with over 12 years of industry experience in clinical development. She has a demonstrated record of success, resulting in regulatory approval and launch of 5 therapeutic agents (Sotrovimab, Lefamulin, Meropenem-Vaborbactam, Minocycline (EU) and Oritavancin) to date and has worked across both small molecules and biologics with deep experience in multiple regulatory submissions including: IND, NDA, BLA, MAA, EUA and global regulatory submissions.
Scientific Advisory Board
Senior Advisors who guide SMAC's scientific and strategic direction.
Evan Tzanis
With over 30 years of experience in the pharmaceutical industry, Evan has played a key role in securing regulatory approval for ten products across a broad range of therapeutic areas. His work has spanned treatments for infectious diseases, dermatological conditions, and central nervous system disorders.
Keith Rodvold, PharmD, FCCP, FIDSA
Clinical pharmacist with 40+ years of expertise in study design and data analysis for conducting clinical pharmacokinetic and pharmacodynamic studies of anti-infective agents. Keith is a Distinguished Professor Emeritus at the University of Illinois Chicago and has authored more than 200 original research and review publications, 60 book chapters, and has edited 6 textbooks.
Sujata Bhavnani, PharmD, MS
Executive Vice-President of Translational Medicine for ICPD (Schenectady, NY) and an Associate Research Professor at the University at Buffalo. Sujata’s extensive experience evaluating exposure-response relationships for antimicrobial agents using pre-clinical and clinical data has been used to support decisions for dose selection and in vitro susceptibility test interpretive criteria for numerous new drug applications.
Mariana Castanheira, PhD
Mariana is the Chief Scientific Officer at JMI Laboratories. Mariana is responsible for designing and overseeing antimicrobial and antifungal drug development projects, surveillance studies, and molecular projects that characterize resistance mechanisms. Mariana is the leading author for over 100 peer-reviewed publications, presents annually at major field conferences, and maintains a global network of research collaborators.